Method for adapting threshold windows, control device, medical treatment apparatus and medical monitoring apparatus

ABSTRACT

The present invention relates to a method of adapting of a second threshold window of at least a second measured variable depending on the change of a first threshold window of a first measured variable, wherein the adaptation is performed by the use of a control unit having been provided and/or configured therefor. The present invention further relates to a control device, a medical treatment apparatus, a medical monitoring apparatus, a digital storage means, a computer program product and a computer program.

CROSS REFERENCE TO RELATED APPLICATIONS

This is a 371 national phase application of PCT/EP2010/007075 filed Nov.23, 2010, which claims priority from German Patent Application No. DE 102009 054 395.3, filed Nov. 24, 2009.

FIELD OF INVENTION

The present invention relates to a method for adapting thresholdwindows. The present invention further relates to a control device, amedical treatment apparatus, a medical monitoring apparatus, a digitalstorage means, a computer program product, and a computer program.

BACKGROUND OF THE INVENTION

Threshold windows for monitored medical measured variables are knownfrom practice. In case the monitored medical measured variable exceedsthe threshold window, a predetermined technical result as, for example,triggering an alarm, can be effected.

During the treatment of, e.g., a medical fluid, adaptation of thresholdwindows of measured variables can be necessary for several reasons.Those reasons include a drift or a permanent change of the absoluteposition of the measured variables due to uncritical reasons as, e.g.,the mere positional change of a patient having his blood treatedextracorporeally.

One object of the present invention is to propose another method foradapting threshold windows. Additionally, appropriate devices areproposed.

This object according to the present invention is achieved by a methodfor adapting threshold windows.

The method according to the present invention comprises adapting asecond threshold window of at least a second, in particular medical,measured variable depending on or based on the change of a firstthreshold window of a first, in particular medical, measured variable.The adaptation is carried out by means of a control device which isprovided and configured correspondingly.

Advantageous embodiments are included as subject matter of the dependentclaims.

In the following description, terms like “can be” or “can have” etc. areintended to be understood as synonyms for “preferably is” or “preferablyhas” etc.

If, in the following, the terms first and second medical measuredvariables, threshold windows or the like are used, a person skilled inthe art will recognize that those terms also include third, fourth orother medical measured variables, threshold windows or the like.

The term “medical measured variable” as used herein denotes a parameteror a characteristic or a state variable which relates to a patient.

A medical measured variable can relate to or be a parameter or acharacteristic or a state variable which is considered upon assessing aclinical state or a change thereof.

The measured variable can be determined, qualified or quantified bydetecting or measuring currently measured values, for example, by usingappropriate detection and/or measurement devices such as sensors.

The terms “first measured variable” and “second measured variable” asused herein can refer to the same kind of measured variable, forexample, a first and a second pressure measured variable. They canindicate an identical measured variable as, e.g., the same pressure,however, being measured twice with different sensors. The first andsecond measured variables can refer to different or differing measuredvariables as, for example, pressure and temperature.

One measured variable can be associated with another measured variable.For example, a second measured variable can depend on a first measuredvariable. However, this does not have to apply.

In the context of a treatment method, examples for medical measuredvariables can include physiological measured variables, in particularvital parameters of a patient, pressure, temperature, time and the like.

The term “patient” as used herein refers to a subject like a human or ananimal independently of being healthy or ill.

The term “threshold window” as used herein refers to a range of valuesor an interval of values about or for a medical measured variable. Thethreshold window can comprise a range of measured values allowable for ameasured variable or indicate or present an interval of values allowablefor a measured variable.

A measured value of a measured variable which is detected to be withinthe threshold window can be regarded as allowable.

In the field of medicine or medicine technology, a threshold window can,for example, be understood as a limitation of a non-pathological scopeor area.

Threshold windows can comprise an upper threshold or upper limit,respectively and/or a lower threshold or lower limit, respectively.Threshold windows can extend from a lower threshold to an upperthreshold, or vice versa, wherein the (upper and/or lower) thresholdscan or cannot be comprised in the range of values.

A threshold window can be a bilaterally or merely unilaterally limitedrange (e.g., having only an upper or a lower limit). Whenever thecontext of the present invention refers to a threshold window, the termis may also be understood as a threshold (for example, an upperthreshold or a lower threshold).

Each measured variable can be assigned one or several threshold windows.

The term “adapting” or “adaptation” of a threshold window as used hereinrefers to a change or offset or adjusting of the range of thresholds ofa medical measured variable due to a change of a first medical measuredvariable or of the threshold window thereof.

The threshold window can be adapted relative to the currently measuredvalue of each measured variable.

Preferably, the threshold window is adapted only after a previousconfirmation by a user.

The term “control device” as used herein refers to a device beingdesigned, configured and/or provided for effecting or triggering anadaptation of the second threshold window depending on a change of afirst threshold window.

The control unit can be embodied to allow an automation or an automaticor automated performance of the method according to the presentinvention.

This can advantageously contribute to reducing the effort necessary foradapting the threshold windows.

The control device can induce or effect the performance of all orsubstantially all method steps. The method according to the presentinvention can substantially or entirely be performed by the controldevice. The method can be performed in part by the control device.

In a preferred embodiment, the second threshold window can be adapted byactuating only one actuation device provided for activating the controldevice.

The actuation or activation of the control device can be effected bypushing, rotating, switching, tipping, touching etc. of the actuationdevice.

Appropriate actuation devices include a knob, a key, a soft key, a hardkey, a switch, a controller, a button of a touch pad, a button of atouch screen, a button which can be actuated or activated by means of anexternal input device like a keypad, a mouse, a pen and the like, aspeech input device and the like.

The actuation can preferably consist of a unique or one-time actuation,respectively, i.e., a unique pushing, tipping, touching etc.

The control device can be activated or actuated by a user as, forexample, clinic staff, e.g., physicians, nursing staff and the like. Theadaptation of the threshold windows is preferably effected by anauthorized person.

The control device can be activated via signal transmission by means ofanother device.

In a further preferred embodiment, the method according to the presentinvention comprises setting or determining a characteristic of at leastone threshold window of a medical measured variable.

The term “characteristic” of a threshold window as used herein refers toa position or an extension of the threshold window, a spatial appearanceof, e.g., a two-dimensionally presented range of values, etc., inrelation to a predetermined value of the measured variable,respectively.

The threshold window can encompass values above such a (predetermined)value of the measured variable and/or values below the value of themeasured variable.

The threshold window can be arranged symmetrically or asymmetricallyabout such a predetermined value of the measured variable, for example,about or around an initial value of the medical variable that could befound at the beginning of a treatment.

The predetermined value of the measured variable can be a referencevalue for the threshold window or for the characteristic thereof.

The characteristic of the threshold window can indicate a relativeposition, relative to a predetermined or detected basic value of themeasured variable or to a detected initial value of the measuredvariable or to an expected value of the measured variable or to anotherwise predetermined or detected value of the measured variable.

The characteristic of the threshold value can be or is individually setfor a patient relative to an initial measured value of a medicalmeasured variable at the beginning of a treatment.

Alternatively, it is possible to change the characteristic of athreshold window or of some or all threshold windows during thetreatment. This can, for example, manually be effected by a user, forexample, by actuating a luffing key for up- or downregulating of singlevalues or ranges of values. This way, post-adapted or post-set thresholdvalues or threshold windows can be used as a basis for the adaptation ofthe second threshold window according to the present invention.

The characteristic can be a width or a height of the threshold windowrelative to an individual measured value of the measured variable orrelative to a predetermined value.

The term “width or height of the threshold window” as used herein refersto an extension of the threshold window from a lower threshold of themedical measured variable to an upper threshold of the medical measuredvariable.

Alternatively, or additionally, the characteristic can be an intervalbetween an upper threshold and/or between a lower threshold and theinitial measured value of the medical measured variable.

The characteristic of the threshold window or threshold windows of oneor several measured variables can, for example, be predetermined orassessed in the so called settings of a medical treatment apparatus.

Presettings for each threshold window having been deposited in thesettings can be consulted or used for adapting the threshold windows.This can preferably be effected automatically by means of a controldevice.

The presettings of all threshold windows to be adapted can be identical.However, the presettings can also differ.

The object of the present invention is further achieved by a controldevice. All advantages achievable by means of the method according tothe present invention can likewise undiminishedly be achieved by thecontrol device according to the present invention.

The control device of the present invention is provided and configuredto be activated or controlled, respectively, in order to adapt a secondthreshold window of at least a second medical measured variabledepending on or based on, respectively, the change of a first thresholdvalue of a first medical measured variable in case of such a change.

The control device of the present invention can be provided andconfigured to be activated in order to perform a method according to thepresent invention.

The control device of the present invention can be provided andconfigured to be activated by a user by actuating only one (single)actuation device.

The object of the present invention is further achieved by a medicaltreatment apparatus and/or by a medical monitoring apparatus. Alladvantages achievable by means of the method according to the presentinvention can likewise be undiminishedly achieved by the medicaltreatment apparatus and/or the medical monitoring apparatus according tothe present invention.

The medical treatment apparatus and/or the medical monitoring apparatusaccording to the present invention comprise at least one control unitaccording to the present invention.

The medical treatment apparatus of the present invention and the medicalmonitoring apparatus of the present invention can be provided and usedas separate units. However, they can also be connected to each other. Inparticular, the monitoring apparatus can be part of the treatmentapparatus. The present invention encompasses all those possibilitiesmentioned above.

The medical treatment apparatus and/or the medical monitoring apparatuscan (each) comprise and/or be connectable to other device likemeasurement and/or detection devices, input or output devices, storagemeans and the like.

The medical treatment apparatus and/or the medical monitoring apparatuscan in particular comprise at least one actuation device. The actuationdevice can be provided and designed for facilitating an activation ofthe control device. Such an activation can, for example, be achieved orinduced by one-time actuating the actuation device.

According to an embodiment of the present invention, the one-timeactuation of the actuation device can be confined to a single orone-time keystroke.

The medical treatment apparatus according to the present invention ispreferably suited for an extracorporeal blood treatment like, forexample, dialysis, hemofiltration, hemodiafiltration, apheresis,adsorption, blood oxygenation and the like. The medical treatmentapparatus according to the present invention can be a cardiopulmonaryapparatus.

In a preferred embodiment, the medical treatment apparatus is a bloodtreatment apparatus for the extracorporeal treatment of blood by meansof at least one of the methods comprising hemodialysis,hemodiafiltration and/or therapeutical apheresis.

The medical treatment apparatus according to the present invention canbe an apparatus for performing a peritoneal dialysis.

The medical monitoring apparatus can be designed and provided orconfigured for monitoring the performance of a medical treatmentprocess, for example, of one of the treatment methods mentioned above.

The object of the present invention is further achieved by a digitalstorage means and/or a computer program product and/or a computerprogram. All advantages achievable by means of the method of the presentinvention can likewise undiminishedly be achieved by these means.

The digital storage means, which is in particular a disc, CD or DVD,preferably features electrically readable control signals which are ableto interact with a programmable computer system such that theautomatically performable steps of the method according to the presentinvention will be executed.

Thereby, all, a few or some of the automatically performable steps ofthe method according to the present invention can be induced. The latteralso applies for the computer program product and the computer program.

The computer program product preferably comprises a program code storedon a machine readable medium for executing a method according to thepresent invention when executing the program product on a computer.

The term “machine readable data medium” as used herein refers to amedium containing data or information being interpretable by softwareand/or hardware. The medium can be a data medium like a disc, a CD, DVDand the like.

The computer program comprises a program code for executing theautomatically performable steps of the method according to the presentinvention when executing the program on a computer.

The method according to the present invention can advantageously servefor facilitating the adaptation of threshold windows. Thus, it can, forexample, advantageously be possible to offset a plurality of thresholdwindows at the same time.

The use of the control device can advantageously contribute in updatingthe medical measured variables detected in or during a treatment in asimple and less complex manner.

The present invention can, therefore, permit a simpler usability and/oroperability of a medical treatment apparatus. It can thus advantageouslybe possible to save time and costs.

Additional advantages include the less possible appearance of falsealarms. Furthermore, there is less possibility of omitting the requiredadaptation of a threshold window for a second, third or another measuredvariable and to thus optionally risk an undesired process routine likean automatic termination of a treatment function.

It should hereby be emphasized that the adaptation is preferably noteffected without any user action; the user must preferably interact inorder to affirm or initiate that an adaptation of the second or otherthreshold window may take place. In such a way, it can advantageously beavoided to miss a change—in particular of a relevant measuredvariable—that may be decisive or relevant.

According to the present invention, the threshold windows are offset oradapted, respectively, by means of the control device—preferably afteraffirmation by the authorized user. Therefore, for example, an alarm(e.g., a pressure alarm) is not triggered only when a second measuredvalue infringes the end of the scale or exceeds a second threshold valuewhich is possibly not valid any more. The new values, pressures, alarmlimits can be offset or adapted, respectively, automatically “throughoutthe system.” It is therefore possible that the user is informed earlierand thus correctly about an infringement of the end of the scale bymeans of a notification or of an alarm.

According to the present invention, by means of this relatively earlynotification in case of an infringement of the end of the scale or avalue exceeding beyond the threshold value, respectively, the user cantake more actions than with known systems. According to the presentinvention, for example, in case of monitoring medical measured variablesduring a blood treatment, there can advantageously remain enough timefor action when considering the pre-filter pressure as indicator forclotting in the filter. Thus, the treatment does not have to beterminated due to a lack of time for responding or for taking action;rather, different measures can still be taken.

Thus, when adequately embodied, the present invention behaves like an“early warning system” such that the user can take the required measureslike, e.g., changing from postdilution to predilution or adapting theanticoagulation at an early stage of time before these measures couldnot be taken any longer. That way, the lifetime of the filter can beincreased. Thus, the present invention can provide economic advantages.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is in the following illustrated by way of examplewith reference to the appended drawing, wherein:

FIG. 1 shows a schematic arrangement of a medical treatment apparatusaccording to the present invention; and

FIG. 2 shows a flow diagram of a method according to the presentinvention.

DETAILED DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a largely schematic arrangement of the medical treatmentapparatus 100 according to the present invention.

The medical treatment apparatus 100 comprises a control unit 1.

The medical treatment apparatus 100 comprises a detection device 3 like,for example, a pressure sensor.

The medical treatment apparatus 100 comprises an input device 5, forexample, a keypad, and an output device 7, for example, a monitor.

The medical treatment apparatus 100 comprises an actuation device 9.

The medical treatment apparatus 100 comprises a monitoring apparatus 11.

As shown in FIG. 1, the monitoring apparatus 11 can be part of themedical treatment apparatus 100. However, according to the presentinvention, the monitoring apparatus 11 can also be used as a separateunit not being part of any treatment apparatus.

FIG. 2 schematically shows a flow diagram of a method according to thepresent invention for adapting a second threshold window depending on achange of a first threshold window.

For easier understanding the co-operation of the single components,reference is made to the arrangement shown in FIG. 1. The componentsinvolved in the method according to the present invention are for thisreason denoted with the reference numerals of FIG. 1 though they are notnecessarily shown in FIG. 2, too.

At the beginning of a treatment, in step S1, a characteristic of thethreshold windows is set for the measured variables which are relevantduring the treatment—this is preferably done individually for eachpatient. The characteristic can, however, also be known before andoptionally be looked up.

Hereto, the user can input the characteristic of the threshold window ofa medical measured variable at issue, e.g., in form of numeric values,into the medical treatment apparatus 100 by means of the input device 5.The threshold windows can be stored in the settings of the medicaltreatment apparatus 100, for example, in an appropriate storage means.

The assessment of threshold windows can be a step of the presentinvention; however, the assessment is not an essential or indispensable,respectively, part of the method of the present invention. As mentionedabove, appropriate threshold windows which have, e.g., previously beendeposited in the settings can be used.

Instructions or requests for the user can be presented by means of theoutput device 7.

During the treatment, a measurement or detection device 3 detects atleast one measured variable relevant for the treatment. The controldevice 1 and/or the user can now study the actual values of the firstmeasured variable and decide based on them if an adaptation of thethreshold window of the first measured variable would be helpful ornecessary.

In case a change of a first threshold window of a first measuredvariable, for example, the venous pressure during a dialysis treatment,is necessary, the user may change the first threshold windowcorrespondingly. Optionally, the user can accept a proposal of thecontrol device by means of confirmation.

To this end, in step S2, the user can first be requested if he wants tochange the first threshold window.

If this is not the case (“N” for NO), the method according to thepresent invention can be terminated (“STOP”).

If the user wants to adapt the first threshold window (“J” for YES), hecan change a characteristic of the first threshold window, for example,a width, an interval between an upper threshold and/or a lower thresholdand the initial measured value of the first measured variable and thelike.

Subsequently, the user can check and confirm the changes he made. If theadaptations were not correct and/or not desired or turned out asunnecessary, the user can reset the threshold window to its originalvalue or its original characteristic, respectively.

Suitable input and/or confirmation devices can be providedcorrespondingly.

Preferably, since the user has to confirm the adaptation of the firstthreshold window, it can advantageously be avoided that the thresholdwindows is adapted in an uncontrolled manner and to thus optionally missa decisive change of the first measured variable.

Upon request, the user decides in step S4 if he wants to automaticallyadapt the second threshold window of the second measured variable, forexample, of the transmembrane pressure, and optionally further thresholdwindows.

The settings necessary for offsetting or adapting the threshold windowscan be deposited in the settings of the medical apparatus. The valuesconcerning the size and/or the position of the threshold window can bemaintained or changed individually. Thus, it can, for example, bepossible to maintain a relative position of the threshold windowrelative to the measured value which has been identified to havetriggered the adaptation.

Thus, in step S4, the user can advantageously be given the possibilityto newly position the threshold windows of all medical measuredvariables, e.g., of all pressure measurement variables, at the sametime.

If the user does not want to adapt the threshold windows (“N” for NO),the method can be terminated (“STOP”).

If the user wants to adapt the threshold windows (“J” for YES), in stepS5 he can activate the control device 1 by means of actuating theactuation device 9 in order to effect or induce an adaptation of thesecond and optionally further threshold windows.

What is claimed is:
 1. A method for adapting threshold windows ofmedical measured variables comprising the steps of: providing a controlunit configured to adapt a second threshold window of at least a secondmeasured variable depending on the change of a first threshold window ofa first measured variable; and, using said control unit to adapt thesecond threshold window of at least the second measured variabledepending on the change of the first threshold window of the firstmeasured variable.
 2. The method according to claim 1, wherein theadapting is effected by actuating only one actuation device foractivating the control unit.
 3. The method according to claim 1, furthercomprising the step of setting or determining a characteristic of atleast one threshold window of a measured variable.
 4. The methodaccording to claim 3, wherein the characteristic of the threshold windowis set in relation to an initially measured value of the measuredvariable for a first patient at the beginning of a treatment for saidfirst patient.
 5. The method according to claim 4, wherein thecharacteristic is a relation between a width of the threshold window andeither a predetermined value or an initially measured value of themeasured variable.
 6. The method according to claim 4, wherein thecharacteristic corresponds to at least one interval selected from thegroup consisting of: an interval between an upper threshold and apredetermined value, an interval between a lower threshold and apredetermined value, an interval between an upper threshold and theinitially measured value of the measured variable, and an intervalbetween a lower threshold and the initially measured value of themeasured variable.
 7. A system comprising a control device which isconfigured to be activated to perform a method according to claim
 1. 8.The system of claim 7, wherein the control device is configured to beactivated by the unique actuation of only one actuation device by a userthereof.
 9. The system of claim 7, wherein the system is a medicaltreatment apparatus comprising said control device.
 10. The systemaccording to claim 9, further comprising at least one actuation deviceconfigured to activate the control device.
 11. The system according toclaim 9, wherein the medical treatment apparatus is blood treatmentapparatus for the treatment of blood by at least one method selectedfrom the group consisting of: hemodialysis, hemofiltration,hemodiafiltration, and therapeutical apheresis.
 12. The system accordingto claim 7, wherein the system is a medical monitoring apparatuscomprising said control device.
 13. The system according to claim 12,further comprising at least one actuation device configured to activatethe control device.
 14. A non-transitory computer-readable storagemedium with an executable program stored thereon, wherein the programinstructs a programmable computer system to execute the technical stepsof a method according to claim 1.